UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015002 |
|---|---|
| Receipt number | R000017449 |
| Scientific Title | studies on the Pathogenesis of Burning Mouth Syndrome |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2018/03/05 20:20:43 |
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Basic information
Public title
studies on the Pathogenesis of Burning Mouth Syndrome
Acronym
Studies on the Pathogenesis of BMS
Scientific Title
studies on the Pathogenesis of Burning Mouth Syndrome
Scientific Title:Acronym
Studies on the Pathogenesis of BMS
Region
| Japan |
Condition
Condition
Burning Mouth Syndrome
Classification by specialty
| Radiology | Anesthesiology | Oral surgery |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate the pathogenesis of BMS
Basic objectives2
Others
Basic objectives -Others
Response to the quantitative stimuli
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specific pain-related sites with fMRI
Diffusion of brain signaling by DTI
Key secondary outcomes
Volumetry of brain structures in BMS patients
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
BMS group: Intervention is applied only on the examination date. Thermal stimuli of 49C and 40 are applied four times each on the right palm or right side of the lower lip.
Interventions/Control_2
Control group: Intervention is applied only on the examination date. The same stimulation to the BMS group is repeated same times at the right palm or right side of the lower lip.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 38 | years-old | < |
Age-upper limit
| 68 | years-old | >= |
Gender
Female
Key inclusion criteria
Sore tongue or mouth
Feel burning pain in the oral cavity
Key exclusion criteria
Those who are taking anxiolytic drugs or antidepressants.
Those who are suffering from brain diseases.
Those who have inflammatory diseases in the oral cavity.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Shinozaki |
Organization
Nihon University School of Dentistry
Division name
Dept of Oral Diagnostic Sciences
Zip code
Address
1-8-13 kandasurugadai, chiyoda-ku, Tokyo, Japan
TEL
03-3219-8089
shinozaki.takahiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Shinozaki |
Organization
Nihon University School of Dentistry
Division name
Dept of Oral Diagnostic Sciences
Zip code
Address
1-8-13 kandasurugadai, chiyoda-ku, Tokyo, Japan
TEL
03-3219-8089
Homepage URL
shinozaki.takahiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Radiology,Nihon University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学医学部板橋病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017449
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
